Enforcement Report - Week of August 28, 2013

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Zimmer continuing investigation and monitoring of the NexGen Cruciate Retaining (CR) Complete Knee System found continued high rates of components used in combinations that are not approved (micro with standard) were implanted. This included the usage of CR Micro Femurs, CR Micro Articular Surface, CR Micro Patellae, CR Micro instruments and provisionals combined with standard components. Although the occurrence has been reduced since the March, 2012 recall, which reiterated proper combination labeling, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices and prevent this issue from recurring in all regions but Japan.